MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION INFINIX-I; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number INFX-8000V

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 06/02/2016

Event Type  malfunction  

Event Description

Employee (catheter lab technologist) was covering c-arm lateral camera for start of non-emergent catheter lab procedure with sterile cover.Sterile cover moved past the front of the camera.Camera is designed to protect the patient by moving back if it senses it is getting to close or touches the patient.The camera appeared to sense resistance as the sterile protective bag was place, moved backward and trapped the employee's left hand between the back of the camera and the docking station.The camera stopped moving.Immediately the employee screamed for help while looking for emergency release on docking station (this c-arm does not have that feature).It was reported that within 5 to 7 seconds the employee pulled out her left hand that had been trapped.The employee has performed this activity many times.The toshiba equipment has been on site > one year.Manufacturer response for fluoroscopic x-ray system, toshiba (per site reporter): toshiba staff evaluated equipment on site and met with (b)(6) staff to understand event.This event review is a collaborative effort.

• Brand Name: INFINIX-I
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 2441 michelle dr.; tustin, CA 92780
• MDR Report Key: 5802672
• MDR Text Key: 49876791
• Report Number: 5802672
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/10/2016,06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: INFX-8000V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other